MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA DUODENOVIDEOSCOPE

Model Number JF-260V

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493)

Event Date 05/16/2019

Event Type  Injury  

Manufacturer Narrative

Model number: the literature described jf-260v and tjf-240, we selected jf-260v as a representative product (same procode).The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported in the literature titled ¿endoscopic side-by-side uncovered self-expandable metal stent placement for malignant hilar biliary obstruction,¿ patients experienced adverse events during or after endoscopic side-by-side uncovered self-expanding metal stent placement procedures using evis lucera duodenoscopes.Study aim: to investigate outcomes of endoscopic bilateral side-by-side placement across the papilla using 10-mm-diameter uncovered self-expandable metal stents for unresectable malignant hilar biliary obstruction.Method: retrospective analysis of 23 patients who underwent endoscopic biliary uncovered self-expandable metal stent placement for unresectable malignant hilar biliary obstruction between january 2015 and september 2016 at one institution.Physicians performed endoscopic side-by-side placement across the papilla using 10-mm-diameter longer-model uncovered self-expandable metal stents.Outcomes included the technical and functional success rates, recurrent biliary obstruction rate, time to recurrent biliary obstruction, reintervention rate, and incidence of adverse events other than recurrent biliary obstruction.Results: of the 23 patients, 10 with malignant hilar biliary obstruction underwent endoscopic side-by-side uncovered self-expandable metal stent placement across the papilla (median age, 83years; 6 men).The locations of malignant hilar biliary obstruction were bismuth types ii (n=3), iii (n=3), and iv (n=4).The median common bile duct diameter was 8mm.The technical and functional success rates were 100% and 80%, respectively.Seven patients (70%) developed recurrent biliary obstruction because of stent occlusions, including early haemobilia in two patients and late tumor growth in five patients.The median time to recurrent biliary obstruction was 66 (95% confidence interval: 29¿483) days.Six patients (60%) required reintervention, and 1 (10%) underwent transcatheter arterial embolization for right hepatic arterial pseudoaneurysm.Early adverse events other than recurrent biliary obstruction occurred in four patients and late adverse event in one patient.Conclusion: endoscopic side-by-side placement across the papilla using 10-mm-diameter uncovered self-expandable metal stents was technically feasible for unresectable malignant hilar biliary obstruction; however, it might be better to avoid this method for patients with malignant hilar biliary obstruction because of high recurrent biliary obstruction rate and shorter time to recurrent biliary obstruction.Early (30 days) adverse events other than rbo occurred in four patients (two cholecystitis, one pancreatitis, and one duodenal bleeding).The two patients with acute cholecystitis underwent gallbladder drainage (one percutaneous transhepatic gallbladder aspiration [ptgba] and one endoscopic ultrasonography-guided gallbladder drainage).One patient had severe acute pancreatitis, which improved with conservative treatment.On the 29th day after sbs usems placement, one patient had duodenal bleeding due to contact with the duodenum of usemss requiring hemostasis with clips.A late (31 days) adverse event occurred in one patient with acute cholecystitis, which improved with ptgba.There is no report of olympus device malfunction described in this study.

Manufacturer Narrative

This report is being supplemented to provide a correction and additional information based on the legal manufacturer's final investigation.New information was added to the following fields: d8, h6, h10.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14083892
• MDR Text Key: 294576705
• Report Number: 8010047-2022-06115
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: JF-260V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/14/2022
• Initial Date FDA Received: 04/12/2022
• Supplement Dates Manufacturer Received: 07/11/2022
• Supplement Dates FDA Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: VISIGLIDE.
• Patient Outcome(s): Other; Required Intervention